Clarity Medical Systems Inc
Clarity Medical Systems Inc appears in FDA public data with 2 recalls, 4 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1265-2014, Class II) was initiated on March 7, 2014. Its most recent 510(k) clearance was granted on April 20, 2011.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 4
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1265-2014 | Class II | Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. G | March 7, 2014 |
| Z-1154-2014 | Class II | RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleas | January 24, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K102859 | RETCAM 3 OPTHALMIC IMAGING SYSTEM | April 20, 2011 |
| K090326 | RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS | November 25, 2009 |
| K083771 | RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP | January 30, 2009 |
| K081858 | RETCAM 3 OPHTHALMIC IMAGING SYSTEM | November 5, 2008 |